Generic Name and Formulations:
Enasidenib 50mg, 100mg; tabs.
Indications for IDHIFA:
Treatment of adults with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test.
Swallow whole. Take at same time each day. Initially 100mg once daily until disease progression or unacceptable toxicity; treat for a minimum of 6 months to allow time for response. Monitoring and dose modifications for toxicities: see full labeling.
Risk of differentiation syndrome (may be fatal if not treated). If differentiation syndrome is suspected, initiate oral or IV corticosteroids and hemodynamic monitoring until resolution; interrupt dose if severe pulmonary symptoms requiring intubation or ventilator support, and/or renal dysfunction persist >48hrs after corticosteroid initiation. Assess blood counts/chemistries for leukocytosis and tumor lysis syndrome prior to initiation; monitor at minimum of every 2 weeks for at least the first 3 months during therapy. Embryo-fetal toxicity. Females of reproductive potential and males (w. female partners) should use effective contraception during and for at least 1 month after final dose. Pregnancy: not recommended (exclude status prior to initiation). Nursing mothers: not recommended (during and for at least 1 month after final dose).
Isocitrate dehydrogenase-2 (IDH2) inhibitor.
May increase or decrease concentrations of combined hormonal contraceptives.
Nausea, vomiting, diarrhea, elevated bilirubin, decreased appetite; differentiation syndrome, leukocytosis, tumor lysis syndrome.
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